Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

Completed

• Conditions: Pulmonary Edema; Hypertension

• Registration Number: NCT00829855
• Lead Sponsor: Carol Davila University of Medicine and Pharmacy

Brief Summary

Acute cardiogenic pulmonary edema (ACPE), one of the most severe forms of acute heart failure, represents 5% of hospital admissions. One of the most frequent phenomena encountered during ACPE is hypertensive crisis (hypertensive ACPE) but the mechanisms and causes of hypertensive ACPE are insufficiently understood. Few studies have evaluated the cardiac function during hypertensive ACPE, and these studies used only conventional echocardiography methods. New methods of evaluation of cardiac function in hypertensive ACPE (such as Tissue Doppler imaging) have not been used.

The objectives of this study are to evaluate presence and role of the following potential mechanisms of hypertensive ACPE: 1. acute myocardial dysfunction (systolic and diastolic); 2. silent transient myocardial ischemia; 3. acute mechanical left ventricular dyssynchrony; 4. dynamic mitral regurgitation; 5. inter-ventricular interaction. Conventional and Tissue Doppler echocardiography will be used to assess cardiac function.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• acute onset of dyspnea within the preceding 8 hours
• respiratory distress and pulmonary rales at any level
• pulmonary congestion confirmed by chest radiography
• systolic blood pressure > 160 mmHg before treatment
• sinus rhythm
• signed informed consent

Exclusion criteria:

• acute myocardial infarction confirmed by myocardial necrosis markers (either CKMB or troponin I). Angina pectoris alone will not be excluded
• significant left sided valvular disease (more than moderate). Mitral regurgitation of any severity will not be excluded, due to the hypothesis of the role of dynamic mitral regurgitation in the pathogenesis of acute hypertensive pulmonary edema
• congenital heart disease
• cardiac tamponade
• rhythm and conduction disturbances that may have precipitated pulmonary edema, like sustained ventricular tachycardia and complete heart block

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony	acute event and 48 to 96 h after the event

Secondary Outcome Measures

Name	Time	Method
surrogate markers of silent transient myocardial ischemia	acute event and 48 to 96 h after the event
dynamic mitral regurgitation	acute event and 48 to 96 h after the event
inter-ventricular interaction	acute event and 48 to 96h after the event

Trial Locations

Locations (1)

Department of Cardiology, University and Emergency Hospital of Bucharest; 🇷🇴 Bucharest, Romania